NCT03793101

Brief Summary

To analyze and compare visual results, keratometry, SIA and HOAs outcomes of biaxial microincision cataract surgery in elderly population, including diabetic and non-diabetic patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 4, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

12 months

First QC Date

December 29, 2018

Last Update Submit

January 3, 2019

Conditions

Cataract Senile

Keywords

BiMICS, biaxial cataract surgery, SIA,diabetes mellitus,

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Snellen charts, EDTRS charts

    3 months

Secondary Outcomes (4)

  • Keratometry

    3 months

  • Surgically Induced Astigmatism, SIA

    3 months

  • Higher Order Aberrations, HOAs

    3 months

  • Corneal Incision thickness

    3 nmonths

Study Arms (2)

BiMICS 1.4

Group 1.4 - Patients operated with 1.4 mm BiMICS technique

Procedure: BiMICS

BiMICS 1.8

Group 1.8 - Patients operated with 1.8 mm BiMICS technique

Procedure: BiMICS

Interventions

BiMICSPROCEDURE

Biaxial microincision cataract surgery implies performing of 2 corneal incisions under 1.8mm, removal of the crystalline lens with the use of ultrasounds and implantation of the artificial intraocular lens.

BiMICS 1.4BiMICS 1.8

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • Clinical diagnose of senile cataract.

You may not qualify if:

  • Eye trauma in anamnesis.
  • Eye surgery in anamnesis.
  • Corneal surgery in anamnesis.
  • Corneal irregular astigmatism.
  • Corneal ectasia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eyemed Centrum Okulistyczne

Lublin, 20-093, Poland

Location

Related Links

Study Officials

  • Paweł Klonowski, MD

    Eyemed Centrum Okulistyczne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Paweł Klonowski Medical Director

Study Record Dates

First Submitted

December 29, 2018

First Posted

January 4, 2019

Study Start

January 1, 2018

Primary Completion

December 12, 2018

Study Completion

December 31, 2020

Last Updated

January 4, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share

UCVA, BCVA, SIA, HOAs, Corneal Incision thickness

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
from August 2019 until December 2020
Access Criteria
only on request
More information

Available IPD Datasets

Clinical Study Report Access

Locations

PL(1)